CFR section
21 CFR 820.80(c): Receiving, in-process, and finished device acceptance
PART 820-QUALITY SYSTEM REGULATION · Subpart H-Acceptance Activities
Key facts
| Citation | 21 CFR 820.80(c) |
|---|---|
| Section | Receiving, in-process, and finished device acceptance |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart H-Acceptance Activities |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Other_Regulations |
| Regulation text (excerpt) | (c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.